Safa A.

Principal Packaging Engineer

AstraZeneca • Temps plein

Apr 2026 - Present • 5 mos

Lead the blister primary packaging and child-resistant walleting strategy for a Phase 3 clinical trial, including the in-process controls for tamper evident seals, and execution at the CMO’s site. • Spearhead packaging development for two autoinjectors and an inhaler, including blister co-packing and secondary/tertiary packaging for three clinical and commercial programs. • Lead secondary packaging design using FEA and manage the shipping qualification studies. • Manage packaging design verification for a multidose pen injector, leading technical layouts, suppliers and CDMO to deliver tooling and qualify the labeling and packaging line for commercial production • Managed the packaging related RFP activities as the technical SME to identify and onboard a new CDMO capable of co-packing inhaler and blisters product.

Sr. Manager, MS&T Drug Product Packaging

Novavax

Nov 2023 - Apr 2026 • 2 yrs 5 mos

Directed global regulatory strategy and submission support across late-stage development and commercialization, preparing and managing responses to the FDA, EMA, and TGA, and partnering cross-functionally with Drug Substance Development, Drug Product, device, QA, and supply chain teams to enable robust end-to-end product delivery. • Led MS&T execution across drug substance downstream manufacturing and PFS drug product packaging, overseeing process validations and PPQs, design controls, and packaging equipment qualification (IQ/OQ/PQ) for both vial and combination products; authored and reviewed 30+ design control documents, shipping and packaging validation technical reports, and executed batch records to support tech transfer, GMP readiness, and manufacturing at CDMOs. • Oversaw global compliance and supply chain integrity across international CDMOs, ensuring adherence to primary/secondary/tertiary packaging requirements, artwork, labeling, and serialization during commercial campaigns.

Process Engineer III

Resilience • Temps plein

Jan 2022 - Nov 2023 • 1 yr 10 mos

Directed the full lifecycle management and validation of a new dedicated secondary and tertiary packaging line (cartoner, labeler, and case packer), including serialization (Tracelink) and aggregation. • Led the CQV program for a new biomanufacturing facility, closing out over 100 critical manufacturing and packaging assets and providing hands-on troubleshooting for aseptic filling machines to ensure operational readiness. • Led the full equipment procurement lifecycle for over 50 critical GMP assets from URS/PO and Factory Acceptance Testing (FAT), through Site Acceptance Testing (SAT). • Accelerated facility operational readiness by 2 months, managing final asset validation (IQ, OQ, PQ) and authorizing SOPs, ensuring immediate audit-readiness for subsequent regulatory inspections.